Fatty acids, C16-18 (even numbered), reaction products with diethylene triamine, di-Me sulfate quaternized

Endpoint summary

Description of key information

- 96-h acute toxicity study, Rainbow trouts (Salmo-Gardia, Shasta, Oncorhynchus mykiss) exposed to Partially unsaturated IQAC, DMS quaternised, 96-h LC50 was 9.84 - 10.24 mg/L (nominal, confidence interval: 2.7 - 11.73 mg a.i./L), read-across

- 48–hr-acute toxicity study, Daphnia Magna exposed to Partially unsaturated IQAC, DMS quaternised, according to OECD Guideline No. 202 (2004) under semi-static conditions. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L), the 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations, read-across

- study according to OECD guideline 201 (adopted 23 March, 2006), GLP, RL1, 10000 cells/mL ( Raphidocelis subcapitata) were exposed for 72h to nominal concentrations of control (0), 0.195, 0.486, 1.22, 3.04 and 7.60 mg a.i./L of Imidazolium compounds, 4,5-dihydro-2-(hydrogenated nortallow alkyl)-1-[2-(hydrogenated tallow amido)ethyl]-1-methyl, Me sulfates under static conditions, 72 hr ErL10: 1.25mg a.i./L,(95% c.l. 0.42 -2.05 mg a.i./L),72 hr ErL50: 6.24mg a.i./L (95% c.l. 4.72 -7.79 mg a.i./L),72 hr NOEL: 1.22mg a.i./L,72 hr EyL10: 1.00mg a.i./L(95% c.l. 0.27 -1.45 mg a.i./L),72 hr EyL50: 2.08mg a.i./L (95% c.l. 1.43 -2.94 mg a.i./L),72 hr NOEL: < 0.19mg a.i./L

- Growth Inhibition Test accordig to OECD 201 with Pseudokirchneriella subcapitata exposed to Partially unsaturated IQAC, DMS quaternised, 72-hour LOEC for the growth rate was determined to be 1.0 mg/L (corresponding to a mean measured concentration of 21 μg/L), 72-hour NOEC for the growth rate was determined to be 0.32 mg/L (corresponding to a mean measured concentration of 7.6 μg/L).  The yield of the algae was also statistically significantly inhibited, 72-hour LOEC was determined to be 0.10 mg/L (corresponding to a mean measured concentration of 2.8 μg/L),72- hour NOEC for yield was determined to be 0.032 mg/L (corresponding to a mean measured concentration of 0.52 μg/L), supporting information from structurally similar substance

- Growth Inhibition Test accordig to OECD 201 with Pseudokirchneriella subcapitata exposed to oleic based IQAC, DMS quaternised, 72h EC50 values for growth rate and yield were calculated to be > 400 µg a.i../L (highest test concentration) and 356 µg test mat./L. The 72h EC10 values were calculated to be 277 and 181 µg a.i./L for growth rate and yield, respectively. The NOEC values for growth rate and yield were estimated to be 178 and 79 µg a.i./L. However, at the LOEC concentration of 267 µg/L for effects on growth rate the inhibition was only 8.1% compared to the controls.This value was statistically significant due to the low variability of the control replicates (1.5 % CV).Since effects below 10 % are generally not considered to be ecotoxicologically relevant, it is recommended to use the growth rate EC10of 277 µg a.i./L as relevant endpoint for the long-term aquatic risk assessment, supporting information from structurally similar substance

Additional information

There are no experimental data available for the target substance tallow/nortallow based IQACs regarding short-term toxicity to fish and short-term toxicity to aquatic invertebrates. However, there are experimental data with the target substance tallow/nortallow based IQACs as well as with the source substances partially unsaturated IQAC, DMS quaternised and oleic acid based IQAC, DMS quaternised regarding toxicity to aquatic algae and cyanobacteria. The target and the source substances show a quite similar ecotoxicological behaviour in the toxicity to aquatic alga and cyanobacteria test, moreover, for this particular class of substances aquatic algae seem to be the most sensitive species, thus, read-cross to the structurally similar IQACs is scientifically justified. A justification for read-acorss is attached to IUCLID section 13.

 

Short-term toxicity to fish:

In a 96-h acute toxicity study, Rainbow trouts (Salmo-Gardia, Shasta,Oncorhynchus mykiss) were exposed topartially unsaturated IQAC, DMS quaternisedat nominal concentrations of 10.0, 13.3, 17.6, 23.3, 30.8 mg test mat. /L.  The 96-h LC50was 9.84 – 10.24 mg act. ingr./L (nominal, Confidence interval: 2.7 - 11.73 mg a.i./L) .  Sublethal effects were not observed. The observed concentration/response curve is very steep. The test material contains considerable amounts of isopropanol. The toxicity of isopropanol against fish is about 100 to 1000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself. This toxicity study is classified as acceptable with restrictions and satisfies the guideline requirement for acute toxicity to fish despite of some deviations that do not invalidate the study.

Results Synopsis Test organism size/age: juvenile rainbow trout (Onchorhynchus mykiss) Test Type: no data, OECD 203 LC50:  9.84 – 10.24 mg a.i./L                        95% C.I.:  2.7 to 11.73 mg a.i./L

 

Short-term toxicity to aquatic invertebrates:

The 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied According to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Results Synopsis

Test Organism Age: < 24 h

Test Type: semi-static

48 -hour NOEC: 0.32 mg/L                                                 (15 μg/L based on mean measured concentrations)

48-hour EC50: 3.7 mg/L; 95% C.l.: 2.6 to 4.9 mg/L (253 μg/L 95% C.I.: 146 to 688 μg/L based on mean measured concentrations)

Endpoint(s) Effected: immobilization

 

The 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed to nominal concentrations of 0, 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1.0 mg test mat. /L for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization were observed.  The 24 – hour EC50was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L.

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself. This study is classifiedscientifically acceptable, that satisfies basic scientific requirements, however not all data are reported.  Results Synopsis Test Organism Age (e.g. 1stinstar): Daphnia magna Test Type: static 24 h EC50:0.45 -0.9 mg a.i. /L 24 h EC0:  0.09 mg a.i./L 24h EC1000:  0.9 mg a.i./L Endpoint(s) Effected: mortality, mobility 

 

Toxicity to aquatic algae and cyanobacteria:

 

In a 72 hour toxicity study according to OECD Guideline 201 (2011), the cultures of Raphidocelis subcapitatawere exposed to Imidazolium compounds, 4,5-dihydro-2-(hydrogenated nortallow alkyl)-1-[2-(hydrogenated tallow amido)ethyl]-1-methyl, Me sulfates at nominal loadings of 0.256, 0.640, 1.60, 4.00 and 10.0 mg test item/Lin growth medium, corresponding to nominal concentrations ofcontrol, 0.195, 0.486, 1.22, 3.04 and 7.60 mg a.i./Lunder static conditions.

The test item has a khown poor water solubility. Due to these properties the test item is difficult to test in aqueous test medium and results from such tests depend from the test settings applied. These condictions normally lead to low analytical recoveries at the end of the exposure. Nevertheless the test item was dispersed in the test medium and therefore available for exposure.

All test concentrations and the control were analytically verified by LC-MS/MS analysis at the start of the exposure (0 hours), 24, 48 hours and the end of the exposure (72 hours).

The measured concentrations of the test item at the start of the exposure were all below the LOQ. Therefore, all values given are nominal exposure concentrations.

The NOEL, EL10 and EL50 based on growth rate inhibition were0.0202 mg a.i./L, 0.205 mg a.i./L (95% c.l. 0.131 – 0.881 mg a.i./L) and 0.407 mg a.i./L (95% c.l. 0.213 – 1.12 mg a.i./L), respectively.

The % growth inhibition in the treated algal culture as compared to the control ranged from 2% to 100%.

The NOEC, EC10 and EC50 based on yield were1.22 mg a.i./L,1.25 mg a.i./L and 6.24 mg a.i./L, respectively.

Microscopic evaluation of the cells at start and the end of the incubation period revealed the following morphological abnormalities: At nominal concentrations of 0.486 and 1.22 mg a.i./L appearance of algal cells was normal but cell debris occurs and at 3.04 and 7.60 mg a.i./L appearance of algal cells was reduced and mainly cells debris was observed.

 

This toxicity study is classified as acceptable and satisfies the guideline requirements for the algal growth inhibition test in Raphidocelis subcapitata.

 

Results Synopsis

Test Organism:Raphidocelis subcapitata

Test Type: Static

 

72 hr ErL10: 1.25mg a.i./L,(95% c.l. 0.42 -2.05 mg a.i./L)

72 hr ErL50: 6.24mg a.i./L (95% c.l. 4.72 -7.79 mg a.i./L)

72 hr NOEL: 1.22mg a.i./L

Endpoint(s) Effected:  growth rate

 

72 hr EyL10: 1.00mg a.i./L(95% c.l. 0.27 -1.45 mg a.i./L)

72 hr EyL50: 2.08mg a.i./L (95% c.l. 1.43 -2.94 mg a.i./L)

72 hr NOEL: < 0.19mg a.i./L

Endpoint(s) Effected:  yield

 

In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata were exposed to Partially unsaturated IQAC, DMS quaternised at nominal concentrations of (0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L) under static conditions in accordance with the according to OECD Guideline 201 (2006). The 72-hour LOEC for the growth rate was determined to be 1.0 mg/L (corresponding to a mean measured concentration of 21 μg/L) and the 72-hour NOEC for the growth rate was determined to be 0.32 mg/L (corresponding to a mean measured concentration of 7.6 μg/L) based on water accommodated fractions (WAFs). The 72-hour LOEC for yield was determined to be 0.10 mg/L (corresponding to a mean measured concentration of 2.8 μg/L) and the 72- hour NOEC for yield was determined to be 0.032 mg/L (corresponding to a mean measured concentration of 0.52 μg/L) based on water accommodated fractions (WAFs).

The measured concentrations in the test media of the two lowest test item treatments with loading rates of 0.010 and 0.032 mg/L were <LOQbio (limit of quantification, 0.614 μg/L). The measured concentrations at the loading rates of 0.10, 0.32, 1.0, 3.2, 10 mg/L were 2.2, 6.2, 11, 14 and 22 μg/L, respectively. The biological results were related to the loading rates of the test item and to mean measured test item concentrations.

There were no compound related phytotoxic effects.

Results Synopsis

Test Organism: Pseudokirchneriella subcapitata

Test Type: Static

Growth

72hr EC10: 2.1 mg/L (31 μg/L measured) 95% C.I.: 1.7 to 2.5 mg/L (27 to 34 μg/L measured)

72hr EC20: 2.9 mg/L (39 μg/L measured) 95% C.I.: 2.6 to 3.3 mg/L (36 to 42 μg/L measured)

72hr EC50: 4.8 mg/L (56 μg/L measured) 95% C.I.: 4.3 to 5.5 mg/L (52 to 61 μg/L measured)

72hr NOEC: 0.32 mg /L (7.6 μg/L measured)

72hr LOEC: 1.0 mg /L (21 μg/L measured)

Yield

72hr EC10: 0.22 mg/L (7.8 μg/L measured) 95% C.I.: 0.11 to 0.35 mg/L (4.2 to 11 μg/L measured)

72hr EC20: 0.43 mg/L (12 μg/L measured) 95% C.I.: 0.26 to 0.61 mg/L (7.6 to 15 μg/L measured)

72hr EC50: 1.5 mg/L (27 μg/L measured) 95% C.I.: 1.2 to 2.0 mg/L (22 to 32 μg/L measured)

72hr NOEC: 0.032 mg /L (0.52 μg/L measured)

72hr LOEC: 0.10 mg /L (2.8 μg/L measured)

In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata were exposed to oleic acid based IQAC, DMS quaternised at nominal concentrations of 79, 119, 178, 267, 400 µg a.i./L under static conditions in accordance with the OECD Guideline 201 (Alga, Growth Inhibition Test).  The EC₅₀values based on growth rate and yield arecalculated to be > 400 µg a.i./L (highest test concentration) and 356 µg a.i./L. The EC₁₀values were calculated to be 277 and 181 µg a.i./L for growth rate and yield, respectively.The NOEC values for growth rate and yield were estimated to be 178 and 79 µg a.i./L.However, at the LOEC concentration of 267 µg a.i./L for effects on growth rate the inhibition was only 8.1% compared to the controls.This value was statistically significant due to the low variability of the control replicates (1.5 % CV).Since effects below 10 % are generally not considered to be ecotoxicologically relevant, it is recommended to use the growth rate EC₁₀of 277 µg a.i./L as relevant endpoint for the long-term aquatic risk assessment.

No cell abnormalities were noted: 

This toxicity study is classified as acceptable and satisfies the guideline requirements for OECD Guideline 201 (Alga, Growth Inhibition Test) toxicity study.

Results Synopsis

Test Organism:

Test Type: Static:

72 hr ErC₅₀:  >400 μg a.i./L                 95% CL  not applicable

72 hr ErC₁₀: 277 μg a.i./L                    95% CL:  239 - 303 µg a.i./L

72.hr NOECr:  178 μg a.i./L               Probit Slope:  -2.01

72 hr EyC₅₀:  356μg a.i./L                   95% CL: 95% CL: 320 - 413 µg a.i./L

72 hr EyC₁₀: 181 μg a.i./L                   95% CL:  95% CL: 126 - 217 µg a.i./L

72.hr NOECy:  79 μg a.i./L                 Probit Slope:  -3.343

Endpoint(s) Effected:  growth rate, yield